This study will test the immune system response to and safety of two HIV vaccines alone and in combination: ALVAC-HIV (vCP1452) and LIPO-5. ALVAC-HIV (vCP1452) uses a canarypox virus with man-made parts of HIV attached to it. The canarypox virus cannot cause disease in people. LIPO-5 is a mixture of five man-made proteins similar to proteins found in HIV.

These vaccines are not produced from live HIV or from infected cells and do not contain the virus. It is not possible to become infected with HIV from these vaccines.

Participants in Groups A will receive four injections over 6 months of either LIPO-5 or a placebo.

Biological: LIPO-5

experimental vaccine

Experimental: B

Participants in Group B will receive four injections over 6 months of either the ALVAC-HIV (vCP1452) or a placebo.

Biological: ALVAC-HIV (vCP1452)

experimental vaccine

Experimental: C

Participants in Groups C will receive six injections over 6 months. Participants in this group will receive either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D, and E.

Biological: ALVAC-HIV (vCP1452)

experimental vaccine

Biological: LIPO-5

experimental vaccine

Experimental: D

Participants in Group D will receive six injections over 6 months. Participants in this group will receive either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D, and E.

Biological: ALVAC-HIV (vCP1452)

experimental vaccine

Biological: LIPO-5

experimental vaccine

Experimental: E

Participants in Group E will receive six injections over 6 months. Participants in this group will receive either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D, and E.

Biological: ALVAC-HIV (vCP1452)

experimental vaccine

Biological: LIPO-5

experimental vaccine

Detailed Description:

Immune priming of cytotoxic T lymphocytes (CTLs) has been most successfully achieved with live attenuated virus or live virus vector vaccines. Recombinant canarypox vaccines have an excellent safety record and have induced HIV neutralizing antibodies and CTLs in early clinical trials. This study will evaluate the use of HIV lipopeptides (LIPO-5) alone and in combination with a canarypox-based HIV vaccine [ALVAC-HIV (vCP1452)] to further increase CTL activity.

Participants in this study will be randomly assigned to one of five groups. Participants in Groups A and B will receive four injections over 6 months. Participants in Group A will receive four injections of either LIPO-5 or a placebo. Participants in Group B will receive four injections of either the ALVAC-HIV (vCP1452) or a placebo. Participants in Groups C, D, and E will receive six injections over 6 months. Participants in these groups will receive either ALVAC-HIV (vCP1452) and LIPO-5 or a placebo. Participants who receive the vaccine combination will receive four injections of the same dose of ALVAC-HIV (vCP1452) and two injections of LIPO-5. The dose of LIPO-5 will be different for participants in Groups C, D, and E.

Participants will have 11 study visits over 18 months; the total duration of the study will be 30 months. The length of visits will vary and may last up to 3 hours. Study visits will include a medical interview, brief physical exam, and blood and urine tests. Participants will be tested for HIV before entering the study and at least five times during the study. All vaccine and placebo injections will be given in the upper arm muscle.

Eligibility

Ages Eligible for Study:

18 Years to 50 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

HIV uninfected

Willing to receive HIV test results

Good general health

Acceptable methods of contraception for females of reproductive potential

Access to participating site and available for follow-up during the study

Exclusion Criteria:

HIV vaccines or placebos in prior HIV vaccine trial

Immunosuppressive medications within 168 days prior to first study vaccine administration

Blood products within 120 days prior to first study vaccine administration

Immunoglobulin within 60 days prior to first study vaccine administration

Live attenuated vaccines within 30 days prior to first study vaccine administration

Investigational research agents within 30 days prior to first study vaccine administration

Subunit or killed vaccines within 14 days prior to first study vaccine administration

Serious adverse reaction to a vaccine. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.

Autoimmune disease or immunodeficiency

Active syphilis

Unstable asthma

Type 1 or Type 2 diabetes mellitus

Thyroid disease requiring treatment in the past 12 months

Serious angioedema within the past 3 years

Uncontrolled hypertension

Bleeding disorder

Malignancy unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period

Seizure disorder requiring medication within the past 3 years

Asplenia

Mental illness that would interfere with compliance with the protocol

Other conditions that, in the judgment of the investigator, would interfere with the study

Pregnant or breast-feeding

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076063

Locations

United States, Alabama

Alabama Vaccine CRS

Birmingham, Alabama, United States, 35294-2041

United States, Maryland

Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore

Baltimore, Maryland, United States

Project Brave HIV Vaccine CRS

Baltimore, Maryland, United States

United States, Massachusetts

Brigham and Women's Hosp. CRS

Boston, Massachusetts, United States, 02115

Fenway Community Health Clinical Research Site (FCHCRS)

Boston, Massachusetts, United States, 02215

United States, Missouri

Saint Louis Univ. School of Medicine, HVTU

St. Louis, Missouri, United States

United States, New York

NY Blood Ctr./Bronx CRS

Bronx, New York, United States, 10456

Univ. of Rochester HVTN CRS

Rochester, New York, United States, 14642-0001

United States, Rhode Island

Miriam Hospital's HVTU

Providence, Rhode Island, United States, 02906

United States, Tennessee

Vanderbilt Vaccine CRS

Nashville, Tennessee, United States, 37232

United States, Washington

FHCRC/UW Vaccine CRS

Seattle, Washington, United States, 98104

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)